Intrinsic Hepcidin IDx Test Information

PLEASE NOTE: Presently the Intrinsic Hepcidin IDxTM Test does not have a CPT code and is not covered by insurance. Thus the cost of the Intrinsic Hepcidin IDxTM Test will be billed directly to the patient or institution. We are working to have the cost of the Intrinsic Hepcidin IDxTM Test covered by all major insurance providers.

Methodology – The Intrinsic Hepcidin IDxTM Test is a monoclonal antibody-based quantitative competitive ELISA, performed in a 96 microwell plate. The test is performed at IntrinsicDxTM, our CLIA certified and CAP accredited clinical laboratory.

Performance Characteristics

Test Parameter

Serum or Li-Heparin Plasma

K2-EDTA Plasma

Specificity

Human hepcidin-25

Human hepcidin-25

Cross Reactivity

No cross-reactivity observed with hepcidin from other

species (rat, mouse) or structurally similar peptides.

Accuracy (vs 2nd generation polyclonal assay)

Slope = 1.06; R = 0.95

Slope = 1.03; R = 0.95

Precision (within run, CV)

98.6 ng/ml = 4%

51.1 ng/ml = 5%

11.8 ng/ml = 7%

152.6 ng/ml = 5%

51.4 ng/ml = 4%

18.4 ng/ml = 9%

Precision (between run, CV)

98.6 ng/ml = 4%

51.1 ng/ml = 8%

11.8 ng/ml = 7%

332.1 ng/ml = 5%

150.6 ng/ml = 3%

16.8 ng/ml = 9%

Precision (between day, CV)

98.6 ng/ml = 4%

51.5 ng/ml = 5%

11.8 ng/ml = 7%

135.5 ng/ml = 10%

47.6 ng/ml = 12%

14.2 ng/ml = 17%

Lower Limit of Detection (LLOD)

1.5 ng/ml

3.8 ng/ml

Lower Limit of Quantitation (LLOQ)

4.0 ng/ml

9.6 ng/ml

Analytical Measurement Range (AMR)

4 – 200 ng/ml

9 – 317 ng/ml

Hepcidin Reference Range (5-95% CI)

Female: 4.4 – 47.3 ng/ml

Male: 6.7 – 85.6 ng/ml

Female: 9.7 – 38.3 ng/ml

Male: 9.4 – 40.5 ng/ml

Hepcidin Stability

Room Temp: 24 hours

2-8 oC: 7 days

-20 oC: 7 days

Room Temp: 24 hours

2-8 oC: 3 days

-20 oC: to be determined

Hepcidin Freeze Thaw Stability

Stable to 4 freeze thaw cycles

Stable to 4 freeze thaw cycles

Hemolysis Interference

Grossly hemolyzed samples are not recommended for analysis

Clinical Significance

The Intrinsic Hepcidin IDxTM Test is a quantitative assay that aids in management of iron-restricted disorders, such as iron deficiency anemia, anemia of inflammation, and iron-refractory iron deficiency anemia (IRIDA). Hepcidin also aids in the management of iron overload disorders, such as hereditary hemochromatosis, and iron-loading anemias.